Pharma’s Pervasive Influence Corrupts Medicine both sides of Atlantic

Pharma’s Pervasive Influence Corrupts Medicine both sides of Atlantic

Tue, 4 Oct 2005

The focus of criticism in medicine has shifted from cost and barriers to access to treatments to an examination of the safety and benefit of current treatments. The pharmaceutical industry’s corrupting influence on physicians, academic researchers, the lay and professional journals, and patient advocacy groups has led to the increasing medicalization of normal human responses to the human condition, including changing life cycles. Central to this trend is that both the drug industry and the medical establishment–doctors especially – have much to gain by medicalizing normal transient discomforts – be it heart burn, menopause, sexual desire, or psychological mood shifts.

Industry’s role in the medicalization of normal responses and in promoting the idea of “a pill for every ill” was of particular concern for the health committee of the UK Parliament, which issued a seminal report (June 2005) calling for a fundamental overhaul of drug development, marketing, and prescribing practices. The committee examined the influence of the drug industry in response to increasing public concern that this influence is excessive and detrimental. In sharp contrast to congressional committee hearings which have never examined the multi-faceted influences that are brought to bear on the conduct of medical research and clinical practice, the committee of Parliament invited testimony from every interested party, including representatives of the drug companies, patients, doctors, medical journal editors, critics of the industry, and government ministers and officials. The report recognized the overriding problem that has derailed medicine from its legitimate course – and that is the pervasive influence of the pharmaceutical industry: “The industry affects every level of healthcare provision, from the drugs that are initially discovered and developed through clinical trials, to the promotion of drugs to the prescriber and the patient groups, to the prescription of medicines and the compilation of clinical guidelines.”

See: House of Commons Health Committee (2005) The influence of the pharmaceutical industry.

The mechanisms by which industry has achieved its extraordinary marketing success–even profiting from products that were found to be defective, some have killed thousands of people–is FDA’s failure to keep unsafe drugs off the market, and by convincing healthy people that they would be better off taking a pill–or better yet, several pills. The latest book that examines this phenomenon, is Selling Sickness by Ray Moynihan and Alan Cassels, which lays bare the maneuvers by which the pharmaceutical industry influences not only physicians’ prescribing but public perception of health and illness: industry’s influence shapes (if not controls) professional medical channels of information, education, and practice guidelines replacing professional know how and judgment with promotional infomercials. Industry’s point of view permeates both the lay and scientific sources of information, and drug companies provide financial support for the dissemination of information skewed in its favor, and support to patient advocacy groups that are enlisted to pitch the latest “condition” for which a drug is at hand.

Richard Smith, the former editor of the BMJ (for 25 years), currently the Chief Executive of United Health Europe, examines key points of the Parliament committee report in PLoS (excerpt below). Smith acknowledges what most physicians do not: “As a doctor myself, I think that doctors are in many ways to blame for the debased relationship between themselves and the industry. The industry is (mostly) behaving in ways that are normal within the commercial sector. It is the doctors who depart from their ethical base when they insist on first-class fares and lavish entertainment from the industry so that they can attend an international conference.”

An essay by Leonore Tiefer, Ph.D., a clinical professor of psychiatry at New York University, and founder of The New View Campaign, a medicalization watchdog group challenges a burgeoning new industry that medicalizes women’s waning sexual desire. The initiative follows the blueprint used to market estrogen-progestogen hormone replacement therapy (HRT) for healthy women. When that medical hoax was unmasked it was revealed that millions of women been deceived by the entire medical establishment for more than 40 years. Doctors who followed industry-influenced professional practice guidelines urged healthy menopausal and post-menopausal women to take HRT assuring them, falsely, that HRT lowered the risk of breast cancer, uterine cancer, heart attacks, stroke, dementia, and more. When women finally learned the truth – that HRT in fact increased these risks and other drug-induced iatrogenic conditions – Wyeth and Eli Lilly lost millions of customers.

To fill the marketing void and regain the women’s menopause market, a group of gynecologists are promoting sexual disinterest (which has never been shown to have a physiological cause) as female sexual dysfunction (FSD), affecting half of menopausal women for whom hormone replacement is recommended – in this case, Proctor & Gamble’s testosterone patch, Intrinsa. But, as Dr. Teifer points out, research on sexual problems is dominated by pharmaceutical industry trials of products, and there is no evidence to demonstrate that by increasing levels of testosterone women’s sexual desire will increase.

The marketing of FSD is almost identical to the marketing of depression, social anxiety disorder, generalized anxiety disorder, ADHD – all hype, no science. Teifer points out the importance of psychosocial variables as causes of women’s sexual problems which under industry’s influence are dismissed. She shows the flawed scientific method noting that the value of testosterone for women’s sexual complaints is overstated, while the dangers in the concurrent and "seemingly mandatory use of estrogen" are ignored. It is astonishing that doctors would ignore an overwhelming body of evidence showing that women who were treated with estrogen-progestogen were put at increased risk of death. Yet, its promoters have no scruples about recommending testosterone, and recommending that some women should take estrogen-progestogen as well.

Primary care physician, Matthew Anderson, hit the nail on the head: “The debate over defining [female sexual dysfunction] is muddied considerably by the overpowering role of the pharmaceutical industry…. [W]ill not the very existence of a highly-promoted pink-pill-equivalent to the “little blue pill” create its own market? Will not a massive ‘health education campaign’ actually change expectations and create a ‘disease’ in women who would otherwise not experience distress?”

Dr. Teifer takes aim at the North American Menopause Society’s (NAMS) position statement, “The role of testosterone therapy in postmenopausal women,” (2005), noting that the conflicts of interest of the NAMS Position Statement authors, consultants, and reviewers were not disclosed. The NAMS position statement – which could be read as an endorsement of Intrinsa – is striking in its resemblance to position statements issued by the psychotropic drug industry’s favorite "patient advocacy group" – the National Alliance for the Mentally Ill (NAMI). As the plight of the mentally ill worsened over the last decade, NAMI’s contribution can be measured in the hugely inflated increased use of psychotropic drugs by adults and especially by children. NAMI has lobbied aggressively for years for INCREASED tax money to pay for UNRESTRICTED use of the latest, most expensive psychotropic drugs. The claims made about those drugs’ safety and efficacy have been proven false.

When the SSRI antidepressants were shown to be no better than placebo yet doubling the risk of suicidal behavior in children, NAMI downplayed the risk and lobbied for screening all children for mental illness. When the atypical antipsychotics were recently unmasked in a major NIMH-sponsored study (CATIE ) which found these drugs to be no more effective nor less hazardous (but much more expensive) than the old drugs for the treatment of schizophrenia – – NAMI is on record defending the drugs even as ¾ of patients could not tolerate their adverse side effects. Whereas CATIE’s principal investigator acknowledged the drugs’ adverse side effects, NAMI’s executive director stated in a letter published in The New York Times: “anosognosia [denial of illness] may have been a factor.”

Curbing the Influence of the Drug Industry: A British View By Richard Smith

—-EXCERPT

Britain’s House of Commons Health Committee has recently recommended a fundamental realignment of the relationships between the pharmaceutical industry and government, regulators, doctors, the health service, and patients….

The committee’s report makes clear that reducing the influence of the industry would be good for everybody, including paradoxically the industry itself, which could concentrate on developing new drugs rather than on corrupting doctors, patient organisations, and others. It is not in the long term interests of the industry for prescribers and the public to lose faith in it, says the report. We need an industry which is led by the values of its scientists not those of its marketing force….

The fundamental problem, says the committee, is that the pharmaceutical industry’s influence is too pervasive: The industry affects every level of healthcare provision, from the drugs that are initially discovered and developed through clinical trials, to the promotion of drugs to the prescriber and the patient groups, to the prescription of medicines and the compilation of clinical guidelines.

Box 2. Recommendations from the Health Committee Enquiry: Some Highlights

The process of licensing drugs, and the medicines’ regulatory system, should both be more transparent.

There should be an independent register of clinical trials.

Clinical trials should focus on using health outcomes that are relevant to patients.

More research should be undertaken into the adverse effects of drugs and the costs of drug-induced illness.

The regulator should ensure greater restraint in medicines’ promotion.

Tougher restriction should be placed on the prescribing activities of non-specialists.

Doctors should be required to declare significant sums or gifts they receive as hospitality.

The sponsorship of the drug industry should pass from the Department of Health to the Department of Trade and Industry" because the secretary of state for health cannot serve two masters (the public and the industry).

(Information taken from [1])

The committee goes into detail about each of these levels. Regulatory authorities, it says, are too close to the industry, meaning that they do not ensure that the industry works in the public interest. The clinical trials that are the essential evidence base for regulatory and clinical decisions are produced almost entirely by the industry, and the evidence that reaches authorities, doctors, and patients is biased. Guidelines for treating patients are distorted, not only because they must be based on biased evidence, but also because the organisations and people producing them are often in hock to the industry. The organisations may receive millions of British pounds for buildings and activities, while the individuals “particularly key opinion leaders (KOLs, as they are known in the trade)"may receive hundreds of thousands of pounds for consultancy, speaking fees, travel, research, and articles. Drug companies are criticised for giving hospitality and recruiting key opinion leaders, says the committee, but the prescribers must be equally to blame for accepting the hospitality and some key opinion leaders for lending their names to work they did not produce, often for very considerable sums.

Next in the list of things that concerned the committee comes the industry’s intensive marketing, which is becoming ever more important as the flow of drugs that offer major therapeutic advances (and so need much less marketing) dries up. Britain has some 8 000 drug company representatives, but the industry also spends millions on advertising, sponsorship, meetings, and increasingly, medical education which often means a fine dinner and a lecture from a captive KOL. The report states: Coupled with company-sponsored information from medical journals and supplements, medical education materials, advertisements and sponsorship to attend conferences, workshops and other events, it is little wonder that prescribing practices are affected. Medical journals, as I’ve argued in PLoS Medicine [3], are in some ways extensions of the marketing arm of the industry, while the free newspapers that overwhelm doctors in the developed world depend 100% on largesse from the industry.

Individual journalists are also captured, the committee heard and perhaps most troublesome is the way patient organisations have become so dependent on the industry. The committee concluded that Measures to limit the influence of industry on patient groups are needed. Currently, in Britain, we see that the patients who are trying to convince the British government that it should ignore the advice of the London-based National Institute of Health and Clinical Excellence (NICE) (which says that drugs for Alzheimer’s disease are not sufficiently cost effective) are in many ways agents of the companies that produce those drugs [6].

The consequences of all of these incestuous relationships, says the committee, are bad decisions on the regulation and prescription of drugs, over-reliance on drugs rather than on other interventions (such as dietary change, exercise, or counselling), and the medicalisation of life’s problems, including baldness, shyness, unhappiness, grief, and sexual difficulties.

Recommendations: Let the Sun Shine In

The committee came up with 48 conclusions and recommendations, and I have listed some of the highlights in mid://00000045/%23BOX2 Box 2. The committee’s main recommendation for the problems it identifies is transparency: let the sun shine in. It begins by recommending that there be a clinical trials register, maintained by an independent body and containing full information. Companies should be required to put the information on the register at launch as a condition of the marketing licence. The committee also wants regulatory authorities and ethics committees (the British equivalent of institutional review boards) to help with the design of trials to make sure that they are answering real questions. It didn’t, however, recommend more public funding of trials. I believe that such funding is necessary in order to ensure that trials are addressing the most important questions including head-to-head comparisons and trials of new drugs against older drugs and non-drug treatments. Advice to companies is unlikely to be effective. … cut ….

On September 8, 2005, a public relations company press release announced a new North American Menopause Society (NAMS) position statement, “The role of testosterone therapy in postmenopausal women.”[1] The full 15-page statement was concomitantly published in the September/October 2005 issue of the NAMS journal, Menopause. [2] At first glance, it appears that this position statement expresses timely and important concerns about the potential overprescription and misprescription of testosterone products as treatments for women’s sexual (and other menopausal) complaints. This worrisome trend has been noted by many, including The New View Campaign, a medicalization watchdog group I founded in 2000 (see http://www.fsd-alert.org). Along with other groups, such as the National Women’s Health Network, Public Citizen’s Health Research Group, and Breast Cancer Action, our New View Campaign group testified against the approval of Intrinsa, Procter & Gamble’s testosterone transdermal system for the treatment of low sexual desire at the Reproductive Advisory Committee meeting of the United States Food and Drug Administration (FDA), which was held on December 2, 2004.[3] Our reasons for recommending rejection had to do with poor data on testosterone safety and efficacy, inadequacies in sexual desire definition, concern about pharmaceutical industry marketing plans, and the overall negative implications of the medicalization of menopause and sexuality.[4] At the conclusion of all the testimony on December 2, the Advisory Committee voted unanimously against approving Intrinsa, and shortly afterwards Procter & Gamble withdrew its application.[5]

Nevertheless, publicity about testosterone as “the hormone of desire” has continued. In the absence of competing publicity about attraction as “the engine of desire,” sex education as “the lubricant of desire,” sensuality as “the foundation of desire,” or a speed-up society as “the death of desire,” physicians continue to receive requests for testosterone treatment. And because of the relaxed rules about off-label prescribing and its widespread practice, [6-9] it seems there is a continuing stream (or is it a flood) of testosterone-using patient-guinea pigs.[10,11] Given the ongoing media and industry hype, it makes sense that NAMS might want to generate a paper presenting the scientific evidence for the use of testosterone in postmenopausal women.

But this NAMS “evidence-based” position statement suffers from some odd lacunae of evidence. The value of testosterone in the treatment of sexual complaints is overstated; the importance of psychosocial variables is dismissed; measurement issues are stated without exploration; dangers in the concomitant and seemingly mandatory use of estrogen with testosterone are underemphasized; conflicts of interest of the position paper’s authors, consultants, and reviewers are omitted, and, perhaps most serious of all, the entire document seems, paradoxically, to represent a covert promotion of one particular testosterone product, Intrinsa, which has been rejected by both the FDA and the European Union.[12]

The New View Campaign Group sees this as a violation of proper medical practice and a flagrant abuse of NAMS’ public platform, and we call on the NAMS membership and Board of Trustees to revise this statement and limit future involvement of pharmaceutical companies in NAMS publications and activities.

Importance of Psychosocial Variables as Causes of Women’s Sexual Problems Dismissed The NAMS position statement fails to consider the implications of the weak empirical relationship between endogenous testosterone and women’s sexual function. The statement acknowledges that “[t]he relationship between endogenous testosterone levels and sexual function in women has not been clearly established…The two largest and most rigorously controlled studies did not find a link.”(p. 500)[2] Thus, scientific evidence does not support the claim that low testosterone levels are a primary cause of women’s sexual complaints. … cut ….

Value of Testosterone for Women’s Sexual Complaints Overstated

An important way in which the NAMS position paper overstates the value of testosterone as a treatment for women’s sexual complaints is by its inattention to the placebo results in the clinical trials on testosterone. The position statement cites only statistical comparisons between testosterone and placebo treatments. Dr. Daniel Davis of the FDA, who was assigned to analyze the efficacy of the testosterone patch for women’s sexual problems, commented at the December 2, 2004 Advisory Committee hearing that there was a “relatively small treatment effect seen with testosterone treatment… [and] there was a strong placebo effect that persisted throughout the two six-month blinded trials.” (pp. 148-149)[3] This “strong placebo effect” was likely due to the psychoeducational component of the placebo intervention, as Dr. Jan Shifren, a lead Intrinsa investigator (and Chair of the NAMS editorial board for the position statement), acknowledged under questioning during the December 2 meeting:

Wearing a non-testosterone-containing patch is a very active intervention…These women were receiving active counseling by the physicians and the nurses that they saw regularly at the study site. They were wearing a patch, which was a clear reminder to both the patient and her partner that she was concerned about her sexual activity, that it distressed her, and that she was committed to making it better. So that just being in the non-testosterone treatment arm was an active intervention. (pp. 250-251, emphasis added)[3]

Procter & Gamble’s publications, of course, have no incentive to include any analysis of the meaning of the placebo results, but it is a serious omission in a professional society position statement claiming to objectively analyze the entire picture of research on testosterone and women’s sexual problems. Taking the placebo results seriously shows that a modest psychoeducational intervention can produce a lasting benefit only slightly less than that of testosterone plus the psychoeducational intervention, even in a sample carefully selected so as to be maximally responsive to testosterone treatment….

Dangers in the Concurrent and Seemingly Mandatory Use of Estrogen

The position paper’s review of testosterone production and metabolism indicates that “spontaneous menopause per se is not associated with a significant change in circulating levels of testosterone…the postmenopausal ovary appears to produce testosterone throughout life.” (p. 499)[2] Thus, levels of testosterone do not decline reliably or inevitably with aging. However, the review also mentions that “[o]ral estrogen therapy, in general, reduces circulating free testosterone levels.” (p. 500)[2] The connection between this finding and the fact that “all trials combined testosterone with either estrogen therapy or, for women with a uterus, estrogen-progestogen therapy” (p. 500, emphasis added)[2] is never discussed. ….cut ….

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